July 16, 2021 – launch at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), a world ophthalmology firm, supplied enterprise and monetary highlights for Q2 2021 for Nicox SA and its subsidiaries (the “Nicox Group”) in addition to an replace on its technique and key anticipated value-inflection milestones at this time.
“Nicox has made robust progress within the second quarter of 2021, with well timed completion of the in-patient a part of the NCX 4251 Mississippi Part 2b trial and continued scientific progress on NCX 470 the place the primary Part 3 outcomes are anticipated in the second quarter of 2022. Our technique stays to retain the complete income potential from our totally–owned, product candidates NCX 470 and NCX 4251 within the U.S. and Europe. We imagine that this presents a better potential return than licensing them to 3rd events and leaves a number of value-creating choices open, together with natural progress and company transactions. We are going to search collaborations for NCX 470 and NCX 4251 in different key areas, together with Japan, following the Mont Blanc and Mississippi trial end results, respectively,” stated Michele Garufi, Chairman and Chief Government Workplacer of Nicox.
“Relating to our partnered business merchandise, VYZULTA and ZERVIATE, now we have seen vital prescription progress in each instances. While income progress has not but caught up attributable to pricing and reimbursement mechanisms frequently skilled within the US market in the first years of launch, we count on to see that comply with via shortly.” added Gavin Spencer, Chief Enterprise Officer of Nicox.
Pipeline Replace and Technique
NCX 470 0.1% ophthalmic resolution: Nicox’s lead scientific product candidate, NCX 470, a novel nitric oxide (NO)-donating prostaglandin analog (PGA), is at the moment in two multi-regional Part 3 glaucoma scientific trials, with top-line outcomes from the primary Part 3 scientific trial, Mont Blanc, anticipated in Q2 2022. Outcomes from the second Part 3 trial, Denali, are anticipated in 2023. Our goal with these two Part 3 scientific trials is to display statistically superior efficacy for the reducing of intraocular stress (IOP) with once-daily dosed NCX 470 0.1% ophthalmic resolution over latanoprost ophthalmic resolution 0.005% (first marketed as Xalatan), probably the most prescribed PGA within the U.S. No monotherapy has beforehand achieved approval within the U.S. primarily based on trials demonstrating scientific proof of superior efficacy to a PGA, which, if achieved, would clearly differentiate NCX 470 from all different monotherapy merchandise accessible available on the market.
Within the Dolomites Part 2 scientific trial, NCX 470 0.065% ophthalmic resolution, a decrease dose than the one being examined in Part 3, already demonstrated a statistically vital enchancment in IOP reducing in comparison with latanoprost. We imagine that the upper dose of 0.1% NCX 470, below analysis within the ongoing Part 3 trials, has the potential to display an excellent higher efficacy than that already noticed within the Dolomites trial. Our ongoing Part 3 program, deliberate and executed along with our Chinese language companion, Ocumension Therapeutics, is predicted to assist NDA submissions within the U.S. and China, and also will present knowledge for nations accepting the identical package deal for approval. Our market analysis suggests peak web gross sales potential for NCX 470 within the U.S. of over $500 million, if accepted and relying on the outcomes of the Part 3 scientific trials, attributable to its distinctive efficacy and security profile, in addition to the selection of latanoprost as a comparator in these trials.
NCX 4251, our novel patented ophthalmic suspension of fluticasone propionate nanocrystals, is at the moment being examined within the Mississippi Part 2b scientific trial which evaluates a once-daily 0.1% dose versus placebo for the remedy of acute exacerbations of blepharitis. The in-patient a part of the trial has been accomplished, and top-line outcomes are anticipated in September 2021. The subsequent steps and timelines within the improvement of NCX 4251, which aren’t at the moment financed, will probably be introduced following an Finish-of-Part 2 assembly with the usFood and Drug Administration, anticipated to happen initially of 2022.
Second Quarter 2021 and Latest Operational Highlights
ophthalmic resolution), 0.24% for the remedy of ocular itching related to allergic conjunctivitis in Mexico. Grin is a Mexican specialty pharmaceutical firm engaged in growing, manufacturing and commercialization of branded ophthalmic merchandise.
Second Quarter 2021 Monetary Highlights
As of June 30, 2021, the Nicox Group had money and money equivalents of €36.5 million as in contrast with €42.0 million at March 31, 2021 and €47.8 million at December 31, 2020. The money at June 30, 2021 is adequate for the Firm to fulfill its present necessities for the following twelve months. Internet income2 for the second quarter of 2021 was €0.7 million (together with €0.6 million of web royalty funds). Internet income2 for the second quarter of 2020 was €0.6 million (completely composed of web royalty funds).
As of June 30, 2021, the Nicox Group had monetary debt of €18.0 million consisting of €16.0 million within the type of a bond financing settlement with Kreos Capital signed in January 2019 and a €2 million credit score settlement with Société Générale and LCL, assured by the French State, and granted in August 2020 within the context of the COVID-19 pandemic.
Solely the determine associated to the money place of the Nicox Group as of December 31, 2020 is audited; all different figures in this press launch are non-audited.
Nicox S.A. is a world ophthalmology firm growing modern options to assist keep imaginative and prescient and enhance ocular well being. Nicox’s lead program in scientific improvement is NCX 470, a novel nitric oxide-donating prostaglandin analog, for reducing intraocular stress in sufferers with glaucoma. The corporate can also be growing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates income from VYZULTA® in glaucoma, licensed completely worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in a number of geographies, together with to Eyevance Prescribed drugs, LLC, within the U.S. and Ocumension Therapeutics within the Chinese language and within the majority of South East Asian markets.
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker image: COX) and is a part of the CAC Healthcare, CAC Pharma & Bio and Subsequent 150 indexes.
For extra info on Nicox, its merchandise or pipeline, please go to: www.nicox.com.